A Phase 3 interventional study of REGN5713 and REGN5715 in Allergic Conjunctivitis, sponsored by Regeneron Pharmaceuticals. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment
This study is researching 2 experimental drugs, REGN5713 and REGN5715, which are called REGN5713-5715 when mixed together (called "study drug") to reduce eye allergy signs and symptoms due to birch tree pollen allergy.
The aim of the study is to see how safe and effective the study drug is at lowering allergic eye signs and symptoms compared with placebo. A placebo looks like a treatment but does not contain any real medicine.
The study is looking at several other research questions, including:
210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.
This study's enrollment of 54 is below the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.
Browse Conjunctivitis, Allergic studies →Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria apply.
Participants will be randomized 1:1
Drug: REGN5713 · Drug: REGN5715
Participants will be randomized 1:1
Drug: Placebo
Ocular itch score in response to birch allergen challenge
Assessed using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale, a 0-4 point scale where 0 = none and 4= incapacitating itch, 0.5 unit increments
Time frame: At Day 8 post-Conjunctival Allergen Challenge (CAC)
Conjunctival redness score in response to birch allergen challenge
Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival \[conjunctival redness scale\] ciliary \[ciliary redness scale\], episcleral \[episcleral redness scale\] vessel beds), a 0 to 4 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments
Time frame: At Day 8 post-CAC
Percent change in birch titrated Skin Prick Test (tSPT) in response to birch allergen challenge
Time frame: Baseline and at Day 8
Tearing score in response to birch allergen challenge
Assessed using the Ora Calibra® Conjunctival Allergen Challenge Tearing Scale, a 0-4 scale where 0 = none and 4 = very severe, 1 unit increments
Time frame: At Day 8 post-CAC
Total ocular symptom score (TOSS) in response to birch allergen challenge
TOSS is a summed score of ocular itch score (graded 0 = none to 4 = incapacitating itch), conjunctival redness score (graded 0 = none to 4 = extremely severe), and tearing score (graded 0 = none to 4 = very severe) for a total range from 0 to 12, where higher scores indicate worse responses.
Time frame: At Day 8 post-CAC
Total redness score in response to birch allergen challenge
The total redness score is calculated for CAC: range 0 to 12, where higher scores indicate worse responses (calculated as a sum of the bilateral averages for conjunctival redness score, graded 0 = none to 4 = extremely severe + ciliary redness score, graded 0 = none and 4 = extremely severe + episcleral redness score, graded 0 = none and 4 = extremely severe)
Time frame: At Day 8 post-CAC
Ciliary redness score in response to birch allergen challenge
Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival \[conjunctival redness scale\] ciliary \[ciliary redness scale\], episcleral \[episcleral redness scale\] vessel beds), a 0 to 4 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments
Time frame: At Day 8 post-CAC
Episcleral redness score
Assessed using the Ora Calibra® Hyperemia Scale (for conjunctival \[conjunctival redness scale\] ciliary \[ciliary redness scale\], episcleral \[episcleral redness scale\] vessel beds), a 0 to 4 point scale, where 0 = none and 4 = extremely severe, 0.5 unit increments
Time frame: At Day 8 post-CAC
Change in birch tSPT
AUC of the mean wheal diameters
Time frame: Baseline and Day 8
Change in birch tSPT
AUC of the mean wheal diameters
Time frame: Baseline and Day 113
Percent change in birch tSPT
AUC of the mean wheal diameters
Time frame: Baseline and Day 113
Change in oak tSPT
AUC of the mean wheal diameter
Time frame: Baseline and Day 8
Percent change in oak tSPT
AUC of the mean wheal diameters
Time frame: Baseline and Day 8
Incidence of Treatment-emergent adverse event (TEAEs)
Time frame: Up to Day 113
Incidence of serious TEAEs
Time frame: Up to Day 113
Incidence of Adverse Events of Special Interest (AESIs)
Time frame: Up to Day 113
Total REGN5713 concentrations in serum over time
Time frame: Up to Day 113
Total REGN5715 concentrations in serum over time
Time frame: Up to Day 113
Incidence of Anti-drug antibody (ADAs) to REGN5713
Time frame: Up to Day 113
Titers of ADAs to REGN5713
Time frame: Up to Day 113
Incidence of ADAs to REGN5715
Time frame: Up to Day 113
Titers of ADAs to REGN5715
Time frame: Up to Day 113
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: When Regeneron has: received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), the legal authority to share the data, and ensured the ability to protect participant privacy.
Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bremzalerbart